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Pharmacokinetics of WCK 2349 In Patients With Hepatic Impairment

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02244827
Recruitment Status : Completed
First Posted : September 19, 2014
Last Update Posted : October 29, 2015
Sponsor:
Information provided by (Responsible Party):
Wockhardt

Brief Summary:
This study is aimed to compare the pharmacokinetics of levonadifloxacin and its sulfate metabolite after a single dose of oral WCK 2349 1000 mg in patients with hepatic impairment and healthy volunteers.

Condition or disease Intervention/treatment Phase
Hepatic Impairment Drug: WCK 2349 Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 48 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: A Phase I, Open Label, Single Dose Study to Evaluate The Pharmacokinetics of WCK 2349 In Patients With Hepatic Impairment
Study Start Date : September 2014
Actual Primary Completion Date : December 2014
Actual Study Completion Date : June 2015

Arm Intervention/treatment
Experimental: WCK 2349
Each subject will receive a single oral dose of WCK 2349 1000 mg (i.e., 2 tablets of 400 mg and 1 tablet of 200 mg) with 240 mL water on Day 1 in the morning. Study drug will be administered after a fast of at least 8 hours.
Drug: WCK 2349
levonadifloxacin (active drug) and the sulfate metabolite
Other Name: levonadifloxacin (active drug)




Primary Outcome Measures :
  1. To compare the pharmacokinetics parameters -AUC,Cmax, tmax, λz, t1/2, systemic clearance and apparent volume of distribution. [ Time Frame: 48 hours ]
    To compare the pharmacokinetics of levonadifloxacin and its sulfate metabolite after a single dose of oral WCK 2349 in patients with hepatic impairment and healthy volunteers


Secondary Outcome Measures :
  1. To evaluate the safety and tolerability parameters- Number of AE , Vital signs, clinical laboratory values, abnormal physical examinations and ECGs [ Time Frame: 7 weeks ]
    To evaluate the safety and tolerability of oral WCK 2349 in patients with hepatic impairment and healthy volunteers



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Body Mass Index (BMI): 18.0 - 38.0 (Body weight in kg / Height in m2), both inclusive.
  • Subjects must fulfill the following criteria:

Patients with hepatic impairment:

  • Considered clinically stable in the opinion of the Investigator
  • Patients with different degrees of impaired hepatic function as assessed by a Child-Pugh classification score: mild (5-6 points), moderate (7-9 points) and severe (10-15 points) impaired hepatic function.
  • Documented history of cirrhosis diagnosed by liver biopsy, ultrasonography (USG), computed tomography (CT) scan, or magnetic resonance imaging (MRI) OR

Healthy volunteers:

  • Have normal hepatic function
  • Participants with a history of self-limited hepatitis A with complete resolution documented at least 6 months prior to entry will be allowed

Exclusion Criteria:

  • Known hypersensitivity to quinolones/fluoroquinolones.
  • Subjects must not fulfill the following criteria:

In hepatically impaired patients:

  • Use of prohibited concomitant medication, with the exception of those essential for the management of hepatic impairment and the treatment of concomitant stable medical conditions for the hepatically impaired patients as per the discretion of the Investigator.
  • Fluctuating or rapidly deteriorating hepatic function as indicated by recent history or widely varying or worsening of clinical and/or laboratory signs of hepatic impairment as judged by the Investigator.
  • Concomitant treatment with Interferon or other prohibited medications
  • Active stage 3 and stage 4 encephalopathy OR

Healthy Volunteers:

  • Use of any concomitant medication within 7 days from the screening except those deemed safe for the study by the Investigator and Medical Monitor.
  • History of any clinically significant chronic and/or active hepatic disease including elevations of serum transaminases including aspartate aminotransferase (AST) and alanine aminotransferase (ALT) [except those which are considered non-significant by the Investigator; however, these should not exceed 1.5 times the Upper Limit of Normal (ULN)], hepatitis (Hepatitis A, B or C), biliary tract disease, or history of any significant gastrointestinal surgery.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02244827


Locations
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United States, Florida
University of Miami,Division of Clinical Pharmacology
Miami, Florida, United States, 33136
Sponsors and Collaborators
Wockhardt
Investigators
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Principal Investigator: Richard A Preston, M.D. Division of Clinical Pharmacology,University of Miami

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Responsible Party: Wockhardt
ClinicalTrials.gov Identifier: NCT02244827    
Other Study ID Numbers: W-2349-102
First Posted: September 19, 2014    Key Record Dates
Last Update Posted: October 29, 2015
Last Verified: October 2015
Additional relevant MeSH terms:
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Liver Diseases
Digestive System Diseases